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RecruitingLast updated: 19 September 2024

PETReA: This phase III trial will assign patients with follicular lymphoma to a certain type of treatment using a PET-scan and assess overall outcomes associated with treatmentPhase 3 evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma

Clinical summary

Summary

Eligible patients will be randomised to receive 375 mg/m2 of intravenous rituximab alone, 375 mg/m2 of intravenous rituximab in combination with oral lenalidomide or no further treatment, based on their response to a PET-scan (positive or negative).

Conditions

This trial is treating patients with follicular lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

PETReA

More information

Trial Identifiers

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Trial sponsor

University of Liverpool

Scientific Title

Phase 3 evaluation of PET-guided, Response-Adapted therapy in patients with previously untreated, high tumour burden follicular lymphoma

Eligibility

Inclusion

1. Must be greater than or equal to 18 years of age at the time of signing the informed consent form.
2. Must be able to adhere to the study visit schedule and other protocol requirements.
3. Must have a documented diagnosis of follicular lymphoma (grade 1, 2 or 3a).
4. Must be at non-contiguous stage II, stage III or stage IV.
5. Must fulfil at least one of the Groupe d'Etude des Lymphomas Folliculaires (GELF) GELF criteria for high tumour burden:
a. Systemic symptoms (> 10% weight loss, temperature greater than or equal to 38°C for more than 5 days, abundant night sweats)
b. Performance status (PS) greater than 1 according to the Eastern Cooperative Oncology Group (ECOG) scale
c. Elevated lactate dehydrogenase (LDH) level
d. ß2-microglobulin level greater than 25.5 nM/L (3 µg/mL)
e. A single lymph node larger than 7 cm
f. Involvement of at least 3 nodal sites, each with diameter greater than 3 cm
g. Marked splenomegaly
h. Organ failure
i. Pleural effusion or ascites
j. Orbital or epidural involvement
k. Blood infiltration
l. Cytopenia
6. Must not have received prior systemic therapy (local radiotherapy is permitted).
7. Must have a WHO performance status score of less than or equal to 2.
8. Must agree to adhere to the Celgene guidance on pregnancy prevention.

Exclusion

1. Any serious medical condition that would prevent the subject from participating in the study.
2. Known active infection with HIV, HBV or HCV.
3. Pregnant or lactating females.
4. Central nervous system involvement as documented by spinal fluid cytology or imaging.
5. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer (TNM stage of T1a or T1b)
6. Any of the following laboratory abnormalities:
a. Absolute neutrophil count (ANC) <1,000/µL (1.0 X 10^9/L)
b. Platelet count <50,000/µL (50 X 10^9/L)
c. Serum alanine transaminase (ALT) > 3.0 x upper limit of normal (ULN)
d. Serum total bilirubin >1.5 x ULN unless due to Gilbert's Syndrome or biliary obstruction by lymphoma

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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